CAB-ROR2-ADC Safety and Efficacy Study in Patients With Solid Tumors

Conditions:Breast Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:June 27, 2018
End Date:May 13, 2022
Contact:Vanessa Esquibel

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A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety,
tolerability, PK, immunogenicity, and antitumor activity of BA3021, a conditionally active
biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2- ADC) in patients with
advanced solid tumors. This study will consist of a dose escalation phase and a dose
expansion phase.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed locally advanced
unresectable or metastatic solid tumor and have failed all available standard of care
(SoC) therapy and for whom no curative therapy is available or who are not eligible,
intolerant to or refuse standard therapy.

- Patients must have measurable disease.

- For the dose expansion phase: Patients with locally advanced unresectable or
metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC)
and soft tissue sarcoma (STS)

- Age ≥ 18 years.

- Adequate renal function

- Adequate liver function

- Adequate hematological function

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Life expectancy of at least three months.

Exclusion Criteria:

- Patients must not have clinically significant cardiac disease.

- Patients must not have known non-controlled CNS metastasis.

- Patients must not have received granulocyte colony stimulating factor (G-CSF) or
granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3021

- Patients must not have had prior therapy with a conjugated or unconjugated auristatin
derivative/vinca-binding site targeting payload.

- Patients must not have Grade 2 or higher peripheral neuropathy.

- Patients must not have known human immunodeficiency virus (HIV) infection, active
hepatitis B and/or hepatitis C.

- Patients must not be women who are pregnant or breast feeding.
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